The EC will make the use of the first four EUDAMED modules mandatory from 28 May 2026

The European Commission has officially published Decision (EU) 2025/2371 in the Official Journal of the European Union, confirming the full operationality of several modules of the European Database on Medical Devices (EUDAMED). This decision, in force since 27 November 2025, marks a decisive step towards the full implementation of this platform at European level.

According to the Commission’s publication, the independent audit of four essential modules of EUDAMED has been successfully completed:

• Registration of economic operators
• UDI database and electronic product registration system
• Notified and certified bodies
• Market surveillance

Following this assessment, the Commission confirms that all of them comply with the functional specifications set out in Article 34 of Regulation (EU) 2017/745. Their use will therefore be mandatory from 28 May 2026.

For economic operators, this update implies a significant change in document management and communication with the competent authorities. The AEMPS recommends taking advantage of the transition periods established in order to ensure compliance with the requirements on time and avoid incidents in the marketing of products.

From 28 May 2026, the national platforms used until now for the registration of the marketing of Medical Devices, RPS and CCPS will no longer be mandatory. The only exception will be the CCPS platform, which will remain mandatory for custom-made medical devices.

From that date onwards, all communications relating to the marketing of medical devices must be made through the EUDAMED platform, which will become the reference system for these procedures.

In this context, CETEM is strengthening its role as a technical partner for companies in the housing sector that work with products eligible for health certification. Its CE health marking services, advice on regulatory requirements and support in certification processes are particularly relevant in view of the mandatory nature of EUDAMED. This will enable companies to approach this transition with greater confidence, reducing regulatory risks and ensuring that their products comply with the new European requirements.

This regulatory update represents a significant step forward in strengthening traceability, safety and transparency in the medical device sector, key aspects for all stakeholders involved in the value chain. CETEM will continue to inform companies and professionals in the sector to facilitate their adaptation to this new European regulatory framework.